Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency

BACKGROUND: Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug A...

Descripción completa

Detalles Bibliográficos
Autores principales: Elsäßer, Amelie, Regnstrom, Jan, Vetter, Thorsten, Koenig, Franz, Hemmings, Robert James, Greco, Martina, Papaluca-Amati, Marisa, Posch, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4196072/
https://www.ncbi.nlm.nih.gov/pubmed/25278265
http://dx.doi.org/10.1186/1745-6215-15-383

Ejemplares similares

Ejemplares similares